FDA 3500A Medical device Adverse Event Report

FDA eSubmitter Screen Shots for eMDR

OMB Control No. 0910-xxxx

Expiration Date xx / xx /xxxx

The public reporting burden for this collection of information has been estimated to average 9 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:

Department of Health and Human Services

Food and Drug Administration

MedWatch HFD-410

5600 Fishers Lane

Rockville, MD 20857

Please DO NOT RETURN this form to this address.

OMB Statement:

“An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

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